FDA Inspection 941272 — James A. Gilligan
The FDA completed an inspection of James A. Gilligan on September 1, 2015 in Woodville, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 1, 2015
- Fiscal Year
- 2015
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Woodville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 13509 | FDCA 402(a)(4) | Individual identity of animal(s) |
| 13521 | 21 CFR 530.41(a) | Drugs prohibited for extralabel use in food-producing animal(s) |
| 1360 | FDCA 501(a)(5) | Expired drugs administered |
| 1362 | 21 CFR 530.11(a) | Species or class |
| 1366 | 21 CFR 530.11(a) | Dosage level |
| 1373 | 21 CFR 530.11(a) | Route of administration |
| 4093 | 21 CFR 530.11(d) | ELDU - producer causes Illegal drug residue |
| 4185 | FDCA 402(a)(4) | Record keeping |